ClearanceBrief
Company

Abbott Medical Optics Inc. (AMO)

FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.

0510(k) clearances (0 in 12 months)
24recalls (0 in 12 months)
2recalls that name a 510(k)

Product codes

CodeDeviceRecords
HQLIntraocular Lens14
LZPAid, Surgical, Viscoelastic7
LPNAccessories, Soft Lens Products2
MLZVitrectomy, Instrument Cutter1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
No clearances in this window.

Latest recalls

DateFirm and productCodeLinked 510(k)
May 16, 2017Abbott Medical Optics Inc. (AMO)
AMO 25GA Vitrectomy Cutter (Model Number NGP0025) and AMO 20GA Vitrectomy Cutter and Irrigation Sleeve (Model Number NGP0020) Used with the AMO Whitestar Signature System. For ophthalmic use.
Terminated
MLZK081681
Apr 1, 2017Abbott Medical Optics Inc. (AMO)
Healon V, Part No. 10290045
Terminated
LZPNone listed
Apr 1, 2017Abbott Medical Optics Inc. (AMO)
Healon Pro, Part No. 10270012
Terminated
LZPNone listed
Apr 1, 2017Abbott Medical Optics Inc. (AMO)
Healon 5 Pro, Part No. 10270015
Terminated
LZPNone listed
Apr 1, 2017Abbott Medical Optics Inc. (AMO)
Healon Duet, Part No. 10290080, 10220010, 10220011 and 10220012
Terminated
LZPNone listed
Apr 1, 2017Abbott Medical Optics Inc. (AMO)
Healon GV, Part No. 10294701, 10294801, 10200014, 10201014, 10202014, 10203014
Terminated
LZPNone listed
Apr 1, 2017Abbott Medical Optics Inc. (AMO)
Healon, Part No. 10290953, 10295210, 10200011, 10200012, 10201012, 10203012, 10213012, 10223012, 10290701, 10294751, 10295701
Terminated
LZPNone listed
Sep 21, 2016Abbott Medical Optics Inc. (AMO)
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model No. Z9002 The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens ha
Terminated
HQLNone listed
Sep 21, 2016Abbott Medical Optics Inc. (AMO)
TECNIS Multifocal Foldable Acrylic Intraocular Lens, Model No. ZMA00 The product is indicated for primary implantation for the visual correction of aphakia in adult patients with and without presbyopi
Terminated
HQLNone listed
Sep 21, 2016Abbott Medical Optics Inc. (AMO)
TECNIS OptiBlue 1-Piece IOL with the TECNIS iTec Preloaded Delivery System, Model No. PCB00V The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a
Terminated
HQLNone listed
Sep 21, 2016Abbott Medical Optics Inc. (AMO)
TECNIS 1-Piece IOL with the TECNIS iTec Preloaded Delivery System, Model No. PCB00 The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractou
Terminated
HQLNone listed
Sep 21, 2016Abbott Medical Optics Inc. (AMO)
SENSAR 1-Piece IOL, Model No. AAB00 The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular catara
Terminated
HQLNone listed
Sep 21, 2016Abbott Medical Optics Inc. (AMO)
TECNIS OptiBlue 1-Piece Intraocular Lens (IOL), Model No. ZCB00V The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been re
Terminated
HQLNone listed
Sep 21, 2016Abbott Medical Optics Inc. (AMO)
TECNIS 1-Piece IOL, Model No. ZCB00 The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular catara
Terminated
HQLNone listed
Sep 21, 2016Abbott Medical Optics Inc. (AMO)
TECNIS Symfony Extended Range of Vision IOL, Model No. ZXR00 The product is indicated primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a
Terminated
HQLNone listed
Sep 21, 2016Abbott Medical Optics Inc. (AMO)
TECNIS Multifocal 1-Piece Intraocular Lens, Model No. ZKB00, ZLB00; The product is indicated for primary implantation for the visual correction of aphakia in adult patients with and without presbyopi
Terminated
HQLNone listed
Sep 21, 2016Abbott Medical Optics Inc. (AMO)
SENSAR Foldable IOL with OptiEdge Design, Model No. AR40e The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed b
Terminated
HQLNone listed
Dec 12, 2014Abbott Medical Optics Inc (AMO)
Abbott Healon EndoCoat Ophthalmic Viscosurgical Device 3% sodium hyaluronate 0.85 mL 30 mg/mL Sterile A Solution Sterile EO Packaging and Cannula Product of USA Abbott Healon Duet Dual Pack 0.55 ml O
Terminated
LZPNone listed
Mar 9, 2013Abbott Medical Optics Inc (AMO)
AMO Sensar Intraocular Lenses (IOLs), Model AR40e, Sensar Foldable IOL with OptiEdge Product Usage: These are ultraviolet-absorbing posterior chamber intraocular lenses for use after cataract extr
Terminated
HQLNone listed
Nov 23, 2011Abbott Medical Optics Inc (AMO)
Sensar Foldable IOL with OptiEdge. Model number AR40e 21.5 Diopter. The Sensar Foldable IOLs with OptiEdge Design are ultraviolet-absorbing posterior chamber intraocular lenses and are indicated for
Terminated
HQLNone listed
Nov 23, 2011Abbott Medical Optics Inc (AMO)
Sensar Foldable IOL with OptiEdge. Model number AR40e, 6.0 Diopter. The Sensar Foldable IOLs with OptiEdge Design are ultraviolet-absorbing posterior chamber intraocular lenses and are indicated for
Terminated
HQLNone listed
Nov 2, 2010Abbott Medical Optics Inc (AMO)
AMO Total Care (1) Contact Lens Solution, Formula: 8772x; Product Code: 90275 (240 ml). Relieves the dryness, irritation, and discomfort that may be associated with contact lens wear.
Terminated
LPNNone listed
Nov 2, 2010Abbott Medical Optics Inc (AMO)
AMO COMPLETE Multi-Purpose Solution, Formula: 9424x; Product Code: 93504 (360ml), 93505 (2x 360ml duo pack), 93515 (240 ml). Cleans, rinses, disinfects, and stores all soft contact lenses and helps
Terminated
LPNK014202
Jan 12, 2010Abbott Medical Optics Inc (AMO)
AMO Tecnis 1-Piece Intraocular Lens (Model ZCB00)
Terminated
HQLNone listed
Get alerts for these product codes